Background: We present the analytical performance of the ivisen IA-1400, a new point-of-care device that features a characteristic built-in centrifuge system, to measure blood cardiac troponin I (cTnI) levels. Methods: Whole blood and plasma samples obtained from patients who visited Korea University Guro Hospital were used to analyze measurement range, cross-reactivity, interference, and sensitivity and specificity. We performed a correlation analysis of the ivisen IA-1400 versus the Access AccuTnI+3 immunoassay using the UniCel™ DxI 800 platform and the PATHFAST™ hs-cTnI assay. Results: Within-run precisions were classified as low, 9.8%; middle, 10.2%; and high, 8.5%. The limit of blank was 3.1 ng/L for plasma samples and 4.3 ng/L for whole blood samples. The limit of detection was 8.4 ng/L for plasma samples and 10.0 ng/L for whole blood samples, respectively. The limit of quantitation at a coefficient of variation of 20% and 10% was 19.5 ng/L and 45.5 ng/L for plasma samples, respectively. The comparative evaluation between the two other assays and ivisen IA-1400 showed excellent correlation, with Spearman's correlation coefficients (R) of 0.992 and 0.985. The sensitivity and specificity of ivisen IA-1400 using the optimum cut-off value of 235 ug/L were 94.6% and 98.2%, respectively. Conclusion: The ivisen IA-1400 showed acceptable and promising performance in cTnI measurements using whole blood and plasma samples, with limited information in the clinical performance. The flexibility for sample selection using the internal centrifugation system is the main advantage of this point-of-care device.
Bibliographical noteFunding Information:
This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HR20C0021) and i-SENS, Inc.
© 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC
- cardiac troponin
- cardiac troponin I
- ivisen IA-1400
ASJC Scopus subject areas
- Immunology and Allergy
- Public Health, Environmental and Occupational Health
- Clinical Biochemistry
- Medical Laboratory Technology
- Biochemistry, medical
- Microbiology (medical)